PMA P990025S031

Device: NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S031
Product code: LPB
Decision date: 2013-03-07
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.

Current openFDA PMA Record#

Device: NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S031
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2013-03-07
Decision code: APPR
Date received: 2012-04-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.